Angioplasty balloon with therapeutic/aspiration channel

ABSTRACT

An angioplasty balloon catheter with an added channel for delivering medication or removing body fluids distal to the site of angioplasty is disclosed. The balloons are especially useful in the treatment of occlusions in saphenous vein grafts, the coronary and carotid arteries, arteries arising from the aorta and branches thereof and in veins flowing to the heart or their tributaries and sub tributaries thereof.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation of application Ser. No. 11/935,131 filed on Nov.5, 2007, which claims priority to 60/857,082 filed Nov. 6, 2006 whichare both incorporated herein by reference.

The present invention relates generally to angioplasty balloons and moreparticularly to angioplasty balloons with therapeutic delivery channels.

FIELD OF THE INVENTION

The present invention relates generally to angioplasty balloons and moreparticularly to angioplasty balloons with therapeutic delivery channels.

BACKGROUND OF THE RELATED ART

Atherosclerosis and cardiovascular disease are leading causes ofmortality and morbidity worldwide. Each process can affect major andminor arterial vessels. Yet while arterial and venous thrombosis havenumerous origins it is at the end organs where the effects of thethrombosis are most felt and where those effects result in clinicalmanifestation. Arterial thrombosis, for example, may manifest as suddencardiac death, acute coronary syndromes (ACS), stroke, or peripheralembolization. Venous thrombosis may manifest as acute deep veinthrombosis (DVT), pulmonary embolism (PE), or paradoxical arterialembolization.

The underlying causes of these manifestations range from atherosclerosisdue to plaque rupture or erosion (e.g., sudden death, ACS, etc), cardiacembolization from atrial fibrillation or left ventricular aneurysm(often secondary to coronary atherosclerosis), stasis and immobility(e.g., postoperative DVT), hypercoagulable state (activated protein Cdeficiency, malignancy), and a variety of rare disorders. Furthermore,thrombosis may complicate the performance of cardiovascular proceduresor initiate malfunction of foreign devices implanted in thecardiovascular system valves, arterial stents, venous filters, bypassgrafts, etc).

Given the deleterious impact of atherosclerosis, various interventionshave been developed to reduce or remove blockages in blood vessels. Onetechnique for treating stenosis or occlusion of a blood vessel isballoon angioplasty. A balloon catheter is inserted into the narrowed orblocked area, and the balloon is inflated to expand the constrictedarea. While commonly performed, this method is not without risk.Embolisms can occur during angioplasty when a blocking materialdislodges and moves downstream further away of the balloon.

In coronary bypass surgery, a more costly and invasive form ofintervention, a section of a vein, such as the saphenous vein taken fromthe kg, is used to form a connection between the aorta and the coronaryartery distal to the obstruction. Over time, however, the saphenous veingraft may itself become diseased, stenosed, or occluded similar to thebypassed vessel. Atherosclerotic plaque in saphenous vein grafts, forexample, tends to be more friable and less fibrocalcific than itscounterpart in native coronary arteries.

Diffusely diseased saphenous vein grafts with friable atheroscleroticlesions and thrombi have been associated with iatrogenic distal embolicdebris. As a result, balloon dilatation (angioplasty) of saphenous veingrafts is more likely to produce symptomatic embolization thandilatation of the coronary arteries. This is the case not only becauseof the difference in the plaque but also because saphenous vein graftsand their atheromatous plaques are generally larger than the coronaryarteries to which they are anastomosed. Once the plaque and thrombi aredislodged from the vein, they can more easily move downstream,completely blocking another portion of the coronary artery and causingmyocardial infarction. In fact, coronary embolisms from saphenous veingraft balloon angioplasty are more likely than in native coronary arteryballoon angioplasty.

Because of these complications and high recurrence rates, old diffuselydiseased saphenous vein grafts have been considered contraindicationsfor standard angioplasty and atherectomy. These complications severelylimit the options for minimally invasive treatment, yet the need forintervention remains.

Embolization is also harmful in patients undergoing interventions on thebranches of the aortic arch (innominate, carotid, subclavian, vertebral)where the distal embolization may be associated with stroke anddevastating neurological deficit. Similarly patients undergoinginterventions to the kidney may have embolization and develop renalfailure.

Given these limitations, considerable effort has been developed to limitembolization using emboli protection devices. Such devices are wellknown to those familiar with the art and comprise filters placed distalto the angioplasty site, occlusion devices placed distal to the site, ordevices placed proximal to the site.

While these devices are effective at capturing detritus such as largeemboli, they may allow small emboli to go across. Further, a reductionin flow across the filter is often noticed when the filter isoverwhelmed. Further still, the embolic detritus can directly impactmicrocirculation and cause impairment of distal organ perfusion.

These complications can lead to myocardial infarction, arrhythmia ordeath during interventions on the coronary arteries or saphenous veingrafts. They can lead to stroke during interventions on the vesselssupplying the brain, renal failure during renal interventions, pulmonaryembolism during venous interventions, etc.

These complications are often treated either by administratingtherapeutic agents to an angioplasty site or by aspirating columns ofblood distal to the angioplasty site. Various agents have been studiedfor improving cell function and have been administered, in differentstudies, before or after angioplasty. These agents include betablockers, adenosine, calcium channel blockers, nitroglycerine,nitroprusside, stem cells, growth factors and combinations thereof.However, given the size of the vessels involved, it is customary toperform angioplasty by removing the angioplasty device, introducing adifferent catheter, and then administering the therapeutic agent oraspiration. Often this necessitates premature removal of the guidewire,which can preclude access to distal vessels and thus is unpopular. Giventhe time delay involved with removing the angioplasty device and theninserting the therapeutic or aspiration mechanism, complications mayresult.

As a result, there is a need for a device that permits delivery of atherapeutic agent distal to the site of angioplasty in a rapid and easyfashion without requiring the removal of the angioplasty device.

SUMMARY OF THE INVENTION

The present application describes angioplasty balloons that have achannel for administering therapeutic agents to a vessel, for example,before, during or after balloon inflation. Also described areangioplasty balloon apparatuses for aspirating body fluids and emboli,thrombi, and other types of particles from a vessel distal to theangioplasty site. Various apparatuses are described, with some beingparticularly well suited for angioplasty within saphenous vein grafts,carotid arteries, coronary arteries, thrombotic AV fistulae and similarvessels.

An embodiment of the present invention is an angioplasty ballooncatheter for administering therapeutic agents or aspirating body fluids,the angioplasty balloon catheter, comprising: an elongate flexibletubular body having a proximal end and a distal end, the body having anouter wall and an inner wall and capable of gaining access into apatient's coronary vessel or non-coronary vessel; a therapeutic lumendefined by the inner wall, the therapeutic lumen having a substantiallyuniformly circular cross-section from the proximal end to the distalend, the therapeutic lumen having a diameter between about 0.01 inchesto about 0.09 inches; a therapeutic port at the proximal end of thetubular body and a therapeutic mouth at the distal end of the tubularbody, the therapeutic port being in fluid communication with thetherapeutic lumen and the therapeutic mouth; a guidewire lumen having aproximal end and a distal opening, wherein the guidewire lumen isadapted to receive a standard-size coronary guidewire therethrough, theguidewire lumen connected to the tubular body and adjacent thetherapeutic lumen such that the therapeutic lumen and the guidewirelumen near the distal end form essentially a figure eight configuration,and such that said therapeutic lumen is unobstructed by said guidewirelumen, wherein the distal opening of the guidewire lumen is distal tothe therapeutic mouth, the therapeutic mouth facing away from theguidewire lumen, whereby the guidewire lumen remains unobstructed duringoperation; and an inflation channel extending through the tubular bodyand capable of delivering inflation pressure to an angioplasty balloon.

Another embodiment of the present invention is a method of applying atherapeutic agent with an angioplasty balloon catheter apparatus, themethod comprising: providing an elongate flexible tubular body havingproximal end, a distal end, an outer wall, and an inner wall forinsertion into a vessel; defining within the tubular body a therapeuticlumen defined by the inner wall, the therapeutic lumen having asubstantially uniformly circular cross-section from the proximal end tothe distal end, the therapeutic lumen having a diameter between about0.01 inches to about 0.09 inches, the therapeutic lumen having atherapeutic port at the proximal end and a therapeutic mouth at thedistal end, the therapeutic port being in fluid communication with thetherapeutic lumen and the therapeutic mouth; providing a guidewire lumenadjacent the therapeutic lumen and having a proximal end and a distalopening, the guidewire lumen being adapted to receive a standard-sizecoronary guidewire therethrough, and positioning the guidewire lumenadjacent to the therapeutic lumen such that the therapeutic lumen andthe guidewire lumen near the distal end form essentially a figure eightconfiguration, and positioning the guidewire lumen to extend distallyfrom the therapeutic mouth; providing an inflation channel extendingthrough the tubular body and capable of delivering inflation pressure toan angioplasty balloon of the catheter; and coupling a therapeuticsource to the therapeutic port for establishing fluid communication withthe therapeutic port for delivering a therapeutic agent to thetherapeutic lumen.

Another embodiment of the present invention is a method of aspirating abody fluid with an angioplasty balloon catheter apparatus, the methodcomprising: providing an elongate flexible tubular body having aproximal end, a distal end, an outer wall, and an inner wall forinsertion into a vessel; defining within the tubular body an aspirationlumen defined by the inner wall, the aspiration lumen having asubstantially uniformly circular cross-section from the proximal end tothe distal end, the aspiration lumen having a diameter between about0.01 inches to about 0.09 inches, the aspiration lumen having anaspiration port at the proximal end and an aspiration mouth at thedistal end, the aspiration port being in fluid communication with theaspiration lumen and the aspiration mouth; providing a guidewire lumenadjacent the aspiration lumen and having a proximal end and a distalopening, the guidewire lumen being adapted to receive a standard-sizecoronary guidewire therethrough, and positioning the guidewire lumenadjacent to the aspiration lumen such that the aspiration lumen and theguidewire lumen near the distal end form essentially a figure eightconfiguration, and positioning the guidewire lumen to extend distallyfrom the aspiration mouth; providing an inflation channel extendingthrough the tubular body and capable of delivering inflation pressure toan angioplasty balloon of the catheter; and coupling a source ofnegative pressure to the aspiration port for establishing fluidcommunication with the aspiration port and aspirating the body fluidthrough the aspiration lumen.

Another embodiment of the present invention is a method stent deliverywith an angioplasty balloon catheter apparatus, the method comprising:providing an elongate flexible tubular body having a proximal end, adistal end, an outer wall, and an inner wall for insertion into avessel; defining within the tubular body a first lumen defined by theinner wall, the first lumen having a port at the proximal end and amouth at the distal end, the port being in fluid communication with thefirst lumen and the mouth; providing a guidewire lumen adjacent thefirst lumen and having a proximal end and a distal opening, theguidewire lumen being adapted to receive a standard-size coronaryguidewire therethrough, and positioning the guidewire lumen adjacent tothe first lumen such that the first lumen and the guidewire lumen nearthe distal end form essentially a figure eight configuration, andpositioning the guidewire lumen to extend distally from the mouth;providing an inflation channel extending through the tubular body andcapable of delivering inflation pressure to an angioplasty balloon ofthe catheter, the inflation channel having a non-inflated state and aninflated state; and positioning a stent on the angioplasty balloon, thestent being in a non-deployed position when the inflation channel is ina non-inflated state and the stent being in a deployed position when theinflation channel is in the inflated state; coupling a therapeuticsource to the first port for delivering a therapeutic agent to the firstlumen or coupling an aspiration source for aspirating body fluid throughthe first lumen; and inflating the inflation channel to place the stentin the deployed state.

The features, functions, and advantages can be achieved independently invarious embodiments of the present invention or may be combined in yetother embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an example angioplasty balloon catheter apparatushaving a therapeutic channel in accordance with an example;

FIGS. 1A-1C illustrate various example orientations for mouth opening ona therapeutic channel in relation to a guidewire channel;

FIG. 1D illustrates a portion of a tubular body in which therapeuticsmay be delivered proximal to a balloon;

FIG. 2 illustrates a cross-sectional view (taken at lines 2-2) of a midportion of the angioplasty balloon catheter of FIG. 1;

FIG. 3 illustrates a cross-sectional view (taken at lines 3-3) of aportion of the angioplasty balloon catheter of FIG. 1 in an example;

FIG. 4 illustrates a cross-sectional view of a portion of theangioplasty balloon catheter of FIG. 1 in another example from that ofFIG. 3;

FIGS. 5A and 5B illustrate cross-sectional views (taken at lines 5-5) ofportions of the angioplasty balloon catheter of FIG. 1 in accordancewith different examples, respectively;

FIGS. 6A and 6B illustrates cross-sectional views (taken at lines 6-6)of a distal portion the angioplasty balloon catheter of FIG. 1 inaccordance with different examples, respectively; and

FIG. 7 illustrates an example angioplasty balloon catheter and stentapparatus having a therapeutic channel in accordance with an example.

DESCRIPTION OF DETAILED EXAMPLES

Example angioplasty balloon catheter apparatuses capable of therapeuticdelivery or aspiration are described. Generally, these apparatusesinclude structures for inserting and inflating angioplasty balloons, aswell as mechanisms for delivering therapeutics or aspiration before,during or after balloon inflation or deflation. The balloon may be amonorail angioplasty balloon, for example, coupled with a therapeuticchannel. A single catheter may provide an angioplasty balloon on ashaft, a guidewire channel that runs along the entire or partial lengthof the shaft, an inflation channel to inflate and deflate the balloon,and a therapeutic aspiration channel for administering a localtherapeutic to the treated region or aspiring the region of blood,emboli, thrombi, etc.

The therapeutic or aspiration channel may be sized and shaped to delivertherapeutic agents and/or remove plaque, thrombi, emboli, and othertypes of detritus from blood vessels distal to the angioplasty site. Thecatheter apparatus may be adapted to be compactly utilized in even thesmaller size blood vessels, such as branches of the coronary vessels orintracranial vessels. The catheter apparatus can also be adapted toprovide efficient and speedy use in larger size vessels. This apparatusmay be formed so as to be compatible with common therapy devices and maybe designed for rapid evacuation and ease of use.

The catheter apparatuses may be provided in either over-the-wire or insingle operator form. Radiopaque markers may be incorporated into thedistal ends of the catheters to facilitate their positioning within thebody. The catheters may be provided with varying flexibility along thelength of the shaft, such that they are soft and flexible enough to benavigated through the vasculature of a patient without causing damage,but are stiff enough to sustain the axial push required to position thecatheter properly and to sustain the aspiration pressures.

FIG. 1 illustrates an example catheter apparatus 10 that comprises anelongate flexible tubular body 100 having a proximal end 102 and adistal end 104. The catheter body or shaft may incorporate areinforcement (not shown) such as a metallic braid or coil or a polymercoil to provide strength and flexibility to the device. A therapeuticlumen (channel) 106 extends the length of the tubular body 100 and has atherapeutic port 108 at the proximal end 102 in fluid communication withthe therapeutic lumen 106, such that therapeutic agents can be deliveredor aspiration pressure can be provided through the port and lumen.

The distal end 104 of the tubular body 100 may be formed of a moreflexible material than that used to form the rest of the catheter shaft.

The therapeutic lumen 106 may be defined by an inner wall of the tubularbody 100 and is preferably substantially uniform and circular incross-section from the proximal end 102 to the distal end 104, althoughthis need not be the case. The therapeutic lumen 106 may have a diameterof between approximately 0.01 inches and approximately 0.09 inches, inan example. The lumen 106 may have a mouth 110 at the distal end 104opposite the port 108 for distally communicating the therapeutic orcollecting detritus or blood during aspiration.

The reinforcement for the tubular body 100 can be formed from a varietyof materials, including polymers, stainless steel, silver or gold platedstainless steel, platinum, nitinol, or a combination thereof. The distalend 104 of the catheter body 100 is preferably more flexible than theproximal end 102. In addition to using different materials for thecatheter, flexibility may be achieved by providing a braid or coildensity at the distal end which is greater or lesser than the braid orcoil density at the proximal end.

The angioplasty catheter also includes a second lumen 112, adjacent thetherapeutic lumen 106 (in cross-section) and adapted to receive aguidewire 114. This guidewire lumen 112 may extend substantially theentire length of the tubular body 100, or (as shown in FIG. 1) mayextend distally from the end 104. For example, the guidewire lumen 112may extend beyond the distal end 104 by approximately 40 mm,approximately 20 mm, or smaller distances as desired. The second lumen112 may contain a slit 116 through a side wall to allow insertion andremoval of the guidewire. In an example, the second lumen 112 has aninner diameter of approximately 0.020 inches to receive a 0.014 inchdiameter guidewire. More generally, in some examples, the lumen 112 mayhave any inner diameter over a range of approximately 0.008 inches toapproximately 0.038 inches.

In some examples, the maximum profile of the apparatus 10 pre ballooninflation may be 1.8 mm at the proximal end 102 and 0.9 mm beyond thedistal end to the channel. The guidewire lumen 112 may be formed of ashaft length of 135 cm, for example, with the guidewire exiting at 30 cmbeyond the distal end 104.

The mouth 110 of the therapeutic lumen 106 and the mouth of theguidewire lumen 112 may form essentially a figure eight shape in endview. In some examples, the guidewire lumen may be within thetherapeutic channel, still forming an essentially figure eightconfiguration. In some examples, the mouth 110 may form an obliqueopening that faces away from the guidewire lumen 112, such as in FIG.1A. In other examples, the mouth 110 may form a transverse opening (suchas in FIG. 1B), may face toward the guidewire lumen 112 (such as in FIG.1C), or may have multiple openings. The proximal end of the guidewirelumen 112 may itself form an oblique opening that faces away from thetubular body 100, towards the tubular body 100, transverse to thetubular body 100 or another orientation.

The angioplasty catheter of FIG. 1 may also include a third, inflationlumen, or channel, (not labeled in FIG. 1) inflating or deflating anangioplasty balloon 118. Example inflation channels are described withreference to FIGS. 2-6B below. The balloon 118 may be an approximately5.5 or 6 mm diameter balloon approximately 20 mm in length for largevessels or an approximately 2.5 or 3 mm diameter balloon approximately12 to 15 mm in length for moderate sized vessels, for example. Theballoon 118 is not limited to these examples, of course.

The distal tip 104 of the tubular body 100 can have at least one or moreside ports 120 (in addition to or in place of the mouth opening 110) todeliver therapeutic agent or to facilitate aspiration. In some examples,the therapeutic channel 106 ends proximal to the end 104 of the ballooncatheter so that drugs may be applied at or proximal to the angioplastysite, which may be useful for reducing local inflammation. FIG. 1D showsan example configuration of a portion of the tubular body 100 where thetherapeutic lumen 106 is terminated internally and proximal to theballoon 118 by a lumen stop 117 extending across the entirecross-section of the lumen 106 in the illustrated example to fullyprevent additional downstream flow. Therapeutic within the lumen 106 isdelivered proximal to the balloon 118 through delivery channels 119formed in the side of the tubular body 100. Although only certainchannels 119 are shown it will be understood that more or fewer channelsmay be provided and at different locations along with tubular body 100.

The distal tip 104 can be tapered, blunt, or angled to create an obliquemouth opening, as demonstrated in the examples of FIGS. 1A-1C. Thecatheter body 100 may comprise or be connected to a valve in fluidcommunication with the lumen 106, to control the application ofaspiration pressure at the distal end of the device, in some examples.The aspiration catheter in some examples may also incorporate variouscoatings, such as hydrophilic or hydrophobic coatings, antithrombogeniccoatings, or a combination thereof.

Further, in some examples, the therapeutic channel can be constructed ina fashion that permits capture of the filter device used downstream ofthe apparatus 10. For example, the apparatus 10 may be used with anemboli protection device, such as a distal filter, distal occlusiondevice, or proximal occlusion device. This could entail the therapeuticport having a single transverse opening ending parallel to the guidewirechannel.

FIG. 2 illustrates a cross-section of the catheter 10 (taken along lines2-2 in FIG. 1) and showing the therapeutic channel 106 and an inflationchannel 122 concentric therewith. The inflation channel 122 surroundsthe channel 106 and likewise may be uniformly circular or C-shaped incross-section.

FIG. 3 illustrates a cross-section of the catheter 10 (taken along lines3-3 in FIG. 1) and showing the therapeutic channel 106, the inflationchannel 122, and the guidewire lumen 112 exterior to the therapeuticchannel 106. The guidewire lumen 112 has an elliptical or oblong profilein the illustrated example, such that a vertical extent (along a radialdirection of the channel 106) is shorter than a lateral extent to reducethe overall profile of the catheter apparatus 10. The guidewire lumen112 is shown formed exterior to a channel attachment seem 124. Theinflation channel 122 surrounds the channel 106 and likewise may beuniformly circular or C-shaped in cross-section.

FIG. 4 illustrates an alternative embodiment similar to that of FIG. 3but with the guidewire lumen 112, in an essentially figure eightconfiguration but) formed interior to the therapeutic channel 106 at aninterior surface of the seem 124.

FIG. 5A illustrates a cross-section (at lines 5-5 of FIG. 1) showing anexterior formed guidewire lumen 112, the inflation channel 122, thetherapeutic channel 106, and the angioplasty balloon 118. Thetherapeutic channel 106 at least at this portion of the tubular body 110is protected against inward deformation pressures (from the inflationchannel 122) by a protective ring 126. The ring 126 may represent adifferent, more resilient material than that remainder of thetherapeutic channel 106, or the ring 126 may be a physical harrierformed to prevent all or substantially all inward de of the therapeuticchannel 106.

The inflation channel 122 may be supplied with a fluid urce forinflating, the balloon 118, e.g., via coupling a fluid source into anopening (not shown) at a proximal of the tubular body 100. Alternativelyto or in addition to forming the ring 126 of a resilient material,inflation can be achieved by forming that portion 122 a of the inflationchannel outer wall coinciding with the balloon 118 with a lessresilient, easier to inflate material. Alternatively still, that portion122 a of the inflation channel outer wall coinciding with the balloon118 may be porous to allow fluid injected into the inflation channel 122to fill the balloon 118. It will be understood that the presentapplication is not limited in regards to inflation technique.

FIG. 5B illustrates another embodiment like that of FIG. 5A, but withthe guidewire lumen 112 interior to the therapeutic channel 106.

FIG. 6A illustrates a cross-section (at lines 6-6 of FIG. 1) of thecatheter 10 at the distal end 104 of the tubular body 100. Asillustrated the guidewire lumen 112 and the therapeutic channel 106 forman essentially figure eight configuration. FIG. 6B illustrates a similarcross-section but with the guidewire lumen 112 shown interior to thetherapeutic channel 106, still forming an essentially figure eightconfiguration.

Described are catheters that may be used for fast and efficientaspiration of the working area surrounding the occlusion in a bloodvessel of for fast and efficient therapeutic delivery. The catheters maybe utilized in a wide range of vessel diameters, including extremelysmall ones. The catheters are easy to use and can quickly andefficiently evacuate occlusions and debris, allowing the physician torestore normal blood flow in these vessels in a very short period oftime.

The catheters may be of combined use as well, providing therapeuticsduring some periods and aspiration during others. And either may beperformed before, during, or after an angioplasty balloon inflation ordeflation.

The assemblies described herein may be formed through techniques such asblow molding or heat shrinking a thermoplastic film or tubing. Extrusiontechniques may be used as well. Suitable materials will be known andinclude, by way of example, PET, polyesters, nylon, PVC, andpolyethylene.

Although shown in a uniform cross-section, the lumens described may betapered toward the distal end and/or toward the proximal end as desired.Further while some inner lumen walls are illustrated as continuouscurves (e.g., circular in cross-section), am of the lumen walls may beelliptical in cross-section or take on other shapes, including havingplanar walls or wall portions. The geometry of the lumen may vary.Further still the lumens may extend the entire linear length of thetubular body or at least some of the lumens (e.g., the guidewire andinflation lumens) may be helically formed to coil around a central axisand body of the therapeutic lumen.

Persons of ordinary skill in the art will appreciate that the disclosedteachings may be used in any number of implementations and any number ofapplications including coronary arteries, carotid arteries, renalarteries and saphenous vein graft applications mentioned above. Theapparatuses and techniques described herein are not limited to aparticular application. Some further examples are provided below, andyet other examples will become apparent by referencing the claims.

Example Cardiac Applications

The techniques described could be used in a variety of applications. Forexample, in treatment for cardiac conditions, such as acute MI and SVGinterventions, the catheter would permit aspiration after and duringangioplasty and thus limit embolization. The catheter would permitdelivery of pharmaceutical agents (such as beta blockers, adenosine,calcium channel blockers, nitroglycerine, nitroprusside, stem cells,growth factors and combinations there the distal bed without having tochange catheters or introduce new devices in the artery. The cathetercould deliver other agents including a naturally occurring substance, anembryonic cell, a fetal cell, a transgenic cell, an adult human cell, amodified cell, a modified cellular agent, a sub-cellular structure, anagent capable of modifying cellular function or structure, or acombination thereof. The catheter could perform aspiration thrombectomyprior to, during, and following angioplasty to remove embolic burden andthus improve distal perfusion. These applications could be combined(e.g., angioplasty and aspiration) to permit more rapid establishment offlow to the distal bed.

Example Carotid Applications

In non-cardiac conditions, the techniques can provide carotidinterventions. For example, the catheter may be used as the standard foradministering the post dilation balloon. This would allow aspiration tobe performed on every patient after post-dilation and reduce the risk ofemboli overwhelming the filter. In patients with occlusion devices, thetechniques could be the preferred post dilation balloon administeringtechniques, since immediate aspiration could be achieved. This wouldreduce the time the vessel is occluded.

Recent data suggest that slow flow occurs in approximately 10% of thecases undergoing protected carotid artery stenting. This phenomenoncommonly occurs following post dilation of a recently deployed carotidstent and is believed to be secondary to release of plaque debris thatoverwhelm the filter. Furthermore, release of plaque components isbelieved to release vasoactive substances that secondarily lead toplatelet activation and aggregation and microthrombi formation. Some ofthese humoral mediators are believed to be responsible for the globalcerebral dysfunction that can follow carotid stenting. Given that thepatients with slow flow are at very high risk of stroke after the filteris removed, it is customary to introduce an aspiration catheter or adiagnostic catheter such a multipurpose catheter to aspirate the columnof blood in the internal carotid artery up to the filter. This strategyis believed to limit the hazard of embolization that may follow removalof the filter.

A potential concern with this strategy is that the longer slow flowpersists, the greater the risk of further thrombosis. Thus the operatorhas to balance the need for efficient removal of the blood column withsuspended plaque debris, with the need to quickly remove the filter.

The current techniques may thus be used as the post stenting angioplastyballoon insertion device. Thus, the balloon may be introduced after thecarotid stem is deployed, and aspiration is performed while the balloonis deflated. Any suspended debris is automatically removed. As a result,no time is wasted in removing the device, checking flow and thenre-introducing another device

It is foreseeable that the same benefits may apply in other non-coronarybeds where embolization may be an issue and thus the catheter devicetechniques may be used in renal interventions or as a stent deliveryvehicle for large arteries such as the subclavian, common carotid, orinnominate arteries. Currently these vessels are stented with limitedprotection since they give rise to multiple branches. However, thepresent techniques would permit creation of reversal of flow while thestent is being deployed and thus limit distal embolization.

FIG. 7 illustrates an example stent apparatus 1000 similar to apparatus10 and therefore bearing like reference numbers. The apparatus 1000includes a deployable stent 1002 shown in a non-deployed positionsurround the balloon 118. The stent 1002 is dilated by the inflation ofthe balloon 118, in the illustrated example. It will be appreciated thatin other examples a self-expandable stent may be used instead with theballoon 118, if there is one, allowing the balloon 118 to be used forangioplasty clearance of detritus only.

In addition to the example of FIG. 7, the angioplasty catheter may beused as a delivery catheter for other in-vessel devices such as in alaser or mechanical atherectomy catheter or ultrasonic or laser plaquemodifying/ablation device. Such devices may be combined with thecatheters described herein for operation within the vessel and before,during, or after therapeutic delivery or aspiration.

Although certain apparatus constructed in accordance with the teachingsof the invention have been described herein, the scope of coverage ofthis patent is not limited thereto. On the contrary, this patent coversall embodiments of the teachings of the invention fairly falling withinthe scope of the appended claims either literally or under the doctrineof equivalents.

1. A method of applying a therapeutic agent with an angioplasty ballooncatheter apparatus, the method comprising: providing an elongateflexible tubular body having a proximal end, a distal end, an outerwall, and an inner wall for insertion into a vessel; defining within thetubular body a therapeutic lumen defined by the inner wall, thetherapeutic lumen having a substantially uniformly circularcross-section from the proximal end to the distal end, the therapeuticlumen having a diameter between about 0.01 inches to about 0.09 inches,the therapeutic lumen having a therapeutic port at the proximal end anda therapeutic mouth at the distal end, the therapeutic port being influid communication with the therapeutic lumen and the therapeuticmouth; providing a guidewire lumen adjacent the therapeutic lumen andhaving a proximal end and a distal opening, the guidewire lumen beingadapted to receive a standard-size coronary guidewire therethrough, andpositioning the guidewire lumen adjacent to the therapeutic lumen suchthat the therapeutic lumen and the guidewire lumen near the distal endform essentially a figure eight configuration, wherein the guidewirelumen is provided on the interior of the tubular body, and positioningthe guidewire lumen to extend distally from the therapeutic mouth;providing an inflation channel extending through the tubular body andcapable of delivering inflation pressure to an angioplasty balloon ofthe catheter; and coupling a therapeutic source to the therapeutic portfor establishing fluid communication with the therapeutic port fordelivering a therapeutic agent to the therapeutic lumen.
 2. The methodof claim 1, comprising delivering the therapeutic agent before ballooninflation.
 3. The method of claim 1, comprising delivering thetherapeutic agent after balloon inflation.
 4. The method of claim 1,comprising delivering the therapeutic agent during balloon inflation. 5.The method of claim 1, wherein the therapeutic agent is a pharmaceuticalagent, a naturally occurring substance, a stem cell, an embryonic cell,a fetal cell, a transgenic cell, an adult human cell, a modified cell, amodified cellular agent, a sub-cellular structure, an agent capable ofmodifying cellular function or structure, or a combination thereof. 6.The method of claim 1, wherein the therapeutic port is used to aspiratethe body fluids distal to the site of angioplasty.
 7. The method ofclaim 1 where the therapeutic port is used to aspirate plaque debrissuspended in a column of blood distal to the site of angioplasty.
 8. Themethod of claim 1, further comprising inserting the tubular body intothe vessel already protected by a previously placed emboli protectiondevice.
 9. The method of claim 8, wherein the emboli protection deviceis a distal filter.
 10. The method of claim 8, wherein the emboliprotection device is a distal occlusion device.
 11. The method of claim8, wherein the emboli protection device is a proximal occlusion device.12. The method of claim 1, further comprising administering thetherapeutic agent before balloon inflation.
 13. The method of claim 1,further comprising administering the therapeutic agent during ballooninflation.
 14. The method of claim 1, further comprising administeringthe therapeutic agent after balloon inflation.
 15. The method of claim1, further comprising aspirating body fluid before, during or afterballoon inflation.
 16. A method stent delivery with an angioplastyballoon catheter apparatus, the method comprising: providing an elongateflexible tubular body having a proximal end, a distal end, an outerwall, and an inner wall for insertion into a vessel; defining within thetubular body a first lumen defined by the inner wall, the first lumenhaving a port at the proximal end and a mouth at the distal end, theport being in fluid communication with the first lumen and the mouth;providing a guidewire lumen adjacent the first lumen and having aproximal end and a distal opening, the guidewire lumen being adapted toreceive a standard-size coronary guidewire therethrough, and positioningthe guidewire lumen adjacent to the first lumen such that the firstlumen and the guidewire lumen near the distal end form essentially afigure eight configuration, wherein the guidewire lumen is provided onthe interior of the tubular body, and positioning the guidewire lumen toextend distally from the mouth; providing an inflation channel extendingthrough the tubular body and capable of delivering inflation pressure toan angioplasty balloon of the catheter, the inflation channel having anon-inflated state and an inflated state; and positioning a stent on theangioplasty balloon, the stent being in a non-deployed position when theinflation channel is in a non-inflated state and the stent being in adeployed position when the inflation channel is in the inflated state;coupling a therapeutic source to the first port for delivering atherapeutic agent to the first lumen or coupling an aspiration sourcefor aspirating body fluid through the first lumen; and inflating theinflation channel to place the stent in the deployed state.
 17. Themethod of claim 16, wherein coupling the therapeutic source to the firstport for delivering the therapeutic agent to the first lumen or couplingthe aspiration source for aspirating the body fluid through the firstlumen occurs before stent deployment.
 18. The method of claim 16,wherein coupling the therapeutic source to the first port for deliveringthe therapeutic agent to the first lumen or coupling the aspirationsource for aspirating the body fluid through the first lumen occursafter stent deployment.
 19. The method of claim 16, wherein coupling thetherapeutic source to the first port for delivering the therapeuticagent to the first lumen or coupling the aspiration source foraspirating the body fluid through the first lumen occurs during stentdeployment.